Safety and Efficacy Evaluation of S (+) -Ketamine for Postoperative Acute Pain in Children in Perioperative Settings: A Multicenter, Randomized, Open-label, Active Controlled Pragmatic Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- The area under the broken line of FLACC scale score
研究概览
简要总结
A multicenter, randomized, open-label, active controlled pragmatic clinical trial that evaluates the safety and efficacy of S (+) -ketamine for postoperative acute pain in children in perioperative settings.
详细描述
Children often suffer acute pain,awakening delirium, anxiety and depression after operation which may affect the recovery of children. S (+) - ketamine has been described to decrease acute pain and opioid consumption,but it needs to confirm for chinese children undergoing surgery.
Objective
To evaluate the analgesic effect of perioperative administration of S (+) - ketamine on postoperative acute pain in children undergoing surgery, and explore the effects of S (+) - ketamine on postoperative awakening delirium, postoperative anxiety and depression mood ,as well find the best usage, including dose, timing, compatibility, and type of operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≤17 years;
- •Scheduled for elective digestive tract surgery, orthopedic surgery, urological surgery , ear surgery or other surgeries under general anesthesia;
- •ASA physical status I～Ⅲ;
- •The informed consent form was signed by the patients or the guardians.
排除标准
- •The expected length of hospital stay of the patient is less than 48h;
- •Patients expected to be admitted to the ICU after surgery;
- •Patients expected to return to the ward with tracheal catheter after surgery;
- •Be allergic to S (+) - ketamine;
- •Patients with severe disorder of consciousness or mental system diseases (schizophrenia, mania, bipolar disorder, psychosis, etc.) or cognitive dysfunction;
- •Patients with congenital heart disease or severely developmental retardation;
- •Patients with any of the following contraindications of S (+) - ketamine:
- •Patients with risk of serious rise of blood pressure or intracranial pressure;
- •Patients with high intraocular pressure (glaucoma) or penetrating ocular trauma;
- •Patients with poorly controlled or untreated hypertension (Resting systolic blood pressure greater than 180 mmHg, or resting diastolic blood pressure greater than 100mmHg);
- •Patients with untreated or undertreated hyperthyroidism.
研究组 & 干预措施
S (+)-Ketamine group
Patients who undergo general anesthesia using S(+)-ketamine hydrochloride for anesthesia induction, maintenance or postoperative analgesia.
干预措施: Conventional therapy + S (+)-Ketamine (Drug)
Control group
Patients who undergo conventional therapy without S (+)-Ketamine hydrochloride injection during perioperative period.
干预措施: Conventional therapy (Drug)
结局指标
主要结局
The area under the broken line of FLACC scale score
时间窗: Hour 0-48 after surgery
Only for children aged 0\~7 years. The score of FLACC Scale is 0-10, the higher the score, the more severe the pain.
The area under the broken line of Numerical Rating Scale score
时间窗: Hour 0-48 after surgery
Only for children aged 8\~17years. The score of Numerical Rating Scale(NRS) is 0-10, the higher the score, the more severe the pain.
Opioid consumption
时间窗: Hour 0-48 after surgery
Total opioid consumption(conversion to equivalent morphine)
次要结局
未报告次要终点
研究者
Weidong Mi
Director of the Department of Anesthesiology, Chinese PLA General Hospital
Chinese PLA General Hospital